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49 Ketogenic Diet Trials Near You
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThe purpose of this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the study drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer therapy in people who are receiving standard treatment with alpelisib and fulvestrant for their metastatic PIK3CA-mutant breast cancer.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Uncontrolled Type 2 Diabetes, Vegetarian, Others
Must Be Taking:Metformin
15 Participants Needed
Ketogenic Diet for Kidney Disease
Columbus, Ohio
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Severe Kidney Disease, Others
Must Not Be Taking:Tolvaptan
20 Participants Needed
Ketogenic Diet vs Mixed Diet for Heart Failure
Columbus, Ohio
This trial is comparing a ketogenic diet and a low-fat diet in people with heart failure and diabetes or related conditions. The goal is to see which diet improves exercise tolerance better. The ketogenic diet helps the body use fat for energy, while the low-fat diet focuses on reducing fat intake.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Type I Diabetes, Severe Kidney Disease, Others
90 Participants Needed
Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and/or ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Sleeping Disorders, Diabetes, Liver, Others
Must Not Be Taking:Diabetic Medications
60 Participants Needed
Ketogenic Diet for Brain Cancer
Columbus, Ohio
This pilot study will be a single center, randomized controlled study of 24 participants with diagnosed BM (various primary disease sites) comparing the effect of a ketogenic (n=12) and AICR (n=12) diet. Potential participants will be identified via medical record reviews and chart reviews. Eligibility of patients will be assessed via medical record review. Randomization will be balanced by blocks of random sizes but no stratification due to the small sample size. Both groups will undergo a 16-week diet intervention where research dietitians will provide educations, recipes and grocery lists on the participants assigned diet. Each group will receive 4-7 days worth of food prior to testing days to both aid in transitioning to each dietary arm and to ensure that the metabolic needs for each arm are met. In an effort to maintain a patient centric focus and monitor changes in quality of life (QOL) all patients will complete psychosocial and behavioral inventories. These inventories aim to capture a holistic view on the proposed nutritional intervention during treatment. Primary outcomes will be determined at baseline, 8 weeks, and 16 weeks while patient-centric outcomes will be assessed every four weeks. Participants will have counseling by the attending physician for additional applicable medications for any treatment related side effects or toxicities. The intervention groups will undergo their randomized dietary regimen for 16 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Whole Brain Radiation, Pregnancy, Small Cell Lung Carcinoma, Leptomeningeal Disease, Type 1 Diabetes, Others
24 Participants Needed
Ketogenic Diet for Spinal Cord Injury
Columbus, Ohio
The purpose of this project is to determine if 5 weeks of ketogenic (KD, high-fat) diet vs. standard diet (SD) significantly improves motor and sensory function, glycemic function, and functional independence in patients with spinal cord injury.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 60
Key Eligibility Criteria
Disqualifiers:Pregnancy, Neurological, Cardiac, Renal, Others
60 Participants Needed
Ketogenic Diet for Rheumatoid Arthritis
Columbus, Ohio
This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Chronic Inflammatory, Autoimmune, Malignancy, Others
Must Be Taking:Dmards, Biological Agents
6 Participants Needed
Ketogenic Diet for Bipolar Disorder
Pittsburgh, Pennsylvania
This trial is testing if a high-fat, low-carb diet can help adults with Bipolar Disorder. The diet increases a substance that might reduce severe mood swings. Researchers will use various methods to study its effects on brain activity and emotions. The diet may have mood-stabilizing properties.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Head Injury, Neurological Disorder, SUD, Others
Must Be Taking:Atypical Antipsychotics, Lithium
107 Participants Needed
DASH vs Low-Carb Diet for Polycystic Ovary Syndrome
Ann Arbor, Michigan
This trial is comparing two diets, the DASH diet and a very low-carbohydrate diet, to see which one better helps adults with polycystic ovary syndrome (PCOS) manage their blood sugar and weight. The DASH diet focuses on healthy foods to lower blood pressure, while the very low-carb diet cuts down on sugars to control blood sugar and weight.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Menopause, Pregnancy, Renal Disease, Others
Must Not Be Taking:Weight Loss Drugs, Psychostimulants, Corticosteroids, Warfarin
214 Participants Needed
Diet Modification for Type 2 Diabetes
Ann Arbor, Michigan
This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months.
Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bariatric Surgery, Vegan, Others
Must Not Be Taking:Weight Loss Medications, Systemic Steroids
180 Participants Needed
Diabetes Prevention Programs for Prediabetes
Ann Arbor, Michigan
This trial is comparing two diet programs to see which one better helps people with prediabetes control their blood sugar and lose weight. One program follows a regular diet, while the other focuses on eating very few carbohydrates. Participants will also attend group classes for support and education.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 75
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Bariatric Surgery, Others
Must Not Be Taking:Anti-obesity, Glucose-lowering, Corticosteroids, Warfarin
300 Participants Needed
Ketogenic Diet for NASH Cirrhosis Weight Loss
Indianapolis, Indiana
This is an open-label, randomized study comparing a monitored ketogenic diet intervention using standard ketogenic diet (SKD) and standard of care (SOC) dietary recommendations for 16 weeks. Subjects enrolled in the standard of care group will receive a voucher to Weight Watchers after study completion.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Hepatocellular Carcinoma, Pregnancy, Alcohol Use, Others
Must Not Be Taking:Weight Loss Drugs
40 Participants Needed
Ketogenic Diet for Cardiovascular Health
University Park, Pennsylvania
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:
* Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
* Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?
Participants will:
* Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
* Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
* Attend 5 fasting visits at the Clinical Research Center for testing
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 45
Key Eligibility Criteria
Disqualifiers:Diabetes, Liver Disease, Cardiovascular Event, Others
Must Not Be Taking:Antihypertensives, Statins, Antidiabetics, Steroids
40 Participants Needed
Ketogenic Diet vs Low-Fat Diet for Alzheimer's Disease
Winston-Salem, North Carolina
The Brain Energy for Amyloid Transformation in AD (Alzheimer's disease) or BEAT-AD study will compare the effects of a ketogenic low-carbohydrate diet and a low-fat diet in adults with mild cognitive impairment. The data collected will help determine whether diet interventions induce changes in cognitive function, cerebral blood flow, and levels of certain proteins and hormones in body fluids.
The study will include volunteers who have mild cognitive impairment, who will be randomly assigned to receive either a ketogenic low-carbohydrate diet or a low-fat diet for 16-weeks, with follow-up assessment 8 weeks after diet completion. Study measures, clinic visits and phone sessions will occur at baseline and throughout the 24-week study.
Participant will follow either a low-carbohydrate or low-fat diet that will be individually planned with help from a study dietitian. After completing the study diet for 16 weeks, participants will resume their normal diet. The final visits will occur at week 24 (8 weeks after the completing the diet). At the end of the 24-week study, participants will be given the opportunity to meet with the study dietitian for education and assistance with planning a healthy diet.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Neurodegenerative Illness, Stroke, Psychiatric Disorders, Diabetes, Others
Must Not Be Taking:Diabetes Medications
120 Participants Needed
Low-Carb vs. Low-Fat Diets for Obesity
Bethesda, Maryland
Background:
In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.
Objective:
To test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.
Eligibility:
Adults aged 19 to 50 years with a body mass index of 25 or more.
Design:
Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.
Participants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants homes. They will eat only the foods delivered.
Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Diabetes, Cancer, Pregnancy, Others
Must Not Be Taking:Diet Medications, Psychiatric Medications
100 Participants Needed
Nicotinamide Riboside + Ketogenic Diet for Fatty Liver Disease
Bethesda, Maryland
Background:
At least 30% of Americans have fatty liver disease. This means that they store too much fat in the liver. At the moment lifestyle changes are the only way to treat this problem.
Objective:
To test how (1) a low-carbohydrate diet and (2) a supplement called nicotinamide riboside (NR) affect how a person s body uses dietary fat.
Eligibility:
Men aged 18 to 65 and women aged 18 to 50 who are healthy volunteers with a body mass index (height to weight ratio) of 25 or more. Adults with maturity-onset diabetes of the young type 2 (MODY2) are also needed.
Design:
Participants with diabetes will have 1 screening visit and a 9-day clinic stay. Healthy volunteers will have 1 screening visit and 2 clinic stays of 1 to 2 weeks each.
During screening, all participants will have a physical exam with blood and urine tests. They will have their heart rhythm measured while riding a gym bike.
NR is a pill taken by mouth. Only healthy volunteers will take the NR, for 14 days at a time, during 1 clinic stay. During their other stay, they will take placebos; these are pills that look like the study supplement but contain no NR.
During each clinic stay, all participants will eat a normal American diet. Then they will eat a ketogenic "low-carb" diet for 5 days.
Participants will have many tests, including:
Sleeping every night and having two 24-hour stays in a special room that measures the gases their body uses and produces.
Drinking a high-fat shake, then remaining seated for 5 hours while their blood and breath are monitored.
Having a substance injected into the arm and remaining seated for 3 hours while their blood is measured.
Wearing monitors to measure their activity levels. Another monitor will measure their blood glucose levels.
Having imaging scans.
...
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Liver Disease, Non-MODY2 Diabetes, Heart Failure, Others
Must Not Be Taking:Diet Medications
100 Participants Needed
Keto Diet vs Standard Cancer Diet for Glioblastoma
Milwaukee, Wisconsin
This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence.
This two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Recurrent Glioblastoma, Genetic Disorders, Pregnancy, Others
170 Participants Needed
Ketogenic Diet for Schizophrenia
Catonsville, Maryland
This trial is testing if a special high-fat, low-carb diet can help people with schizophrenia who don't get better with regular medications. The diet changes how the body gets energy, which might improve brain function and reduce symptoms. The ketogenic diet has shown benefits in epilepsy and other neurological conditions, suggesting it may also help with psychiatric conditions.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 64
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Heart Failure, Others
Must Be Taking:Antipsychotics
50 Participants Needed
Ketogenic Diet for High Cholesterol
Saint Louis, Missouri
Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39
Key Eligibility Criteria
Disqualifiers:Hypertension, Diabetes, Tobacco Use, Others
Must Not Be Taking:Lipid-lowering Drugs, Oral Contraceptives
100 Participants Needed
Ketogenic Diet for Type 1 Diabetes
Saint Louis, Missouri
Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Gastroparesis, Hypertension, Pregnancy, Others
Must Be Taking:Insulin
58 Participants Needed
Why Other Patients Applied
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
Specific Diets for Obesity
Saint Louis, Missouri
The purposes of this study are: 1) to determine the mechanisms responsible for the development of cardiometabolic complications in some, but not all people with obesity; 2) determine the best dietary approach for cardiometabolic health; and 3) understand why some people have a stable metabolic phenotype over time whereas cardiometabolic health improves or worsens in others.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Diabetes, Cancer, Psychiatric Illness, Others
Must Not Be Taking:Steroids, Anticoagulants, Others
300 Participants Needed
Ketogenic Diet for Alcohol Metabolism
Philadelphia, Pennsylvania
The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:21 - 50
Key Eligibility Criteria
Disqualifiers:Major Psychiatric Disorder, Epilepsy, Diabetes, Others
Must Not Be Taking:Anticholinergics, Antipsychotics, Lithium, Psychotropics
20 Participants Needed
Ketogenic Diet for Endometrial Cancer
Basking Ridge, New Jersey
The purpose of this study is to test any good and bad effects of an experimental diet, called a ketogenic diet, in endometrial cancer. A ketogenic diet is one that is very low in carbohydrates (simple and complex sugars). The goal of this diet is for the body to go into a state of ketosis. Ketosis is when the body does not have enough sugar for energy so it burns stored fats which create acids called ketones, which can be used for energy. Researchers hope to learn whether or not a ketogenic diet is well-tolerated and safe to eat before surgery in endometrial cancer patients.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Gout, Heart Failure, Others
Must Not Be Taking:Oral Hypoglycemics, Insulin, Corticosteroids
19 Participants Needed
Paxalisib + Metformin + Ketogenic Diet for Glioblastoma
New York, New York
This trial is for patients with new or recurring aggressive brain cancer called glioblastoma. They will take two drugs regularly and follow a high-fat, low-carb diet. The treatment aims to block cancer growth signals and reduce the energy supply to cancer cells.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, QT Interval ≥ 450 Msec, Ongoing Malignancy, Others
Must Be Taking:Paxalisib, Metformin
33 Participants Needed
Ketogenic Diet + Metformin for Glioblastoma
New York, New York
This trial is for men and women with aggressive brain tumors. It uses a high-fat, low-carb diet and a diabetes medication to lower blood sugar levels. The goal is to see if this approach can help slow down tumor growth. The high-fat, low-carb diet is being explored as an additional treatment for brain tumors, with some studies suggesting it may help control tumor growth and improve response to standard treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Other Malignancy, Alcoholism, Others
Must Be Taking:Metformin
36 Participants Needed
Ketogenic Diet for Obesity
Birmingham, Alabama
The goal of this clinical trial is to investigate whether a Ketogenic Diet (KD) can increase Total Energy Expenditure (TEE), while benefiting appetite, during weight loss maintenance in reduced-obese individuals.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cognitive Impairment, Diabetes, Others
Must Not Be Taking:Glucocorticoids, GLP-1 Analogues, Others
20 Participants Needed
Dietary Interventions for Osteoarthritis Pain
Birmingham, Alabama
Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. Non-Hispanic Black individuals (NHB) report greater disability and pain severity compared to Non-Hispanic Whites (NHW). These differences are reinforced through social and biological mechanisms, ultimately resulting in disparities in pain experience and associated quality of life. National efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological alternative. However, racial differences exist in metabolism that are rarely addressed in diet intervention studies. Therefore, a LCD may have greater pain-reducing effects in NHBs and provide an alternative treatment for pain. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables.
Aim 1: To investigate the efficacy of the LCD to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: self-reported pain and evoked pain when compared to the USDA diet.
Hypothesis 2: The LCD group will show greater improvements in: QOL, mood, and self-reported improvement.
Hypothesis 3: Both diets will result in improved pain disability, severity, catastrophizing and pain-related fear; the LCD will outperform the USDA diet.
Objective 2: To explore racial differences in diet effects and baseline measures.
Hypothesis 1: NHBs will show greater improvements in pain, QOL, and mood. Hypothesis 2: NHBs will report greater food insecurity and less proximity to grocery stores.
Hypothesis 3: Diet quality will be negatively associated with baseline pain sensitivity.
Objective 3: To determine whether physiological variables contribute to diet effects or lack thereof.
Hypothesis 1: Baseline physiological measures will predict: pain sensitivity and reductions in pain. NHBs will show greater inflammation at baseline than NHWs.
Hypothesis 2: Change in physiological measures will be related to: change in pain, change in QOL, self-reported improvement and mood. NHWs will show greater reductions in inflammation and adiposity than NHBs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 75
Key Eligibility Criteria
Disqualifiers:Diabetes, Eating Disorders, Cardiovascular, Others
Must Not Be Taking:Opioids, Metabolism-altering, Anti-hypertensives
200 Participants Needed
Diet and Cognitive Training for Blood Cancer Survivors
Birmingham, Alabama
The goal of this clinical trial is to examine feasibility of a cognitive intervention program in blood cancer survivors. The main questions it aims to answer are:
* is it feasible to combine a ketogenic diet supplementation and online cognitive training in an intervention program
* will patients using the combined intervention program have improved cognitive functioning compared to those who don't use it
* how long will the intervention programs effects last
Participants randomized to the intervention arm will consume an exogenous ketogenic supplementation and use an online cognitive training program for 12 weeks, while waitlist arm functions as a control group and will receive the online cognitive training only after a wait period of 12 weeks. Researchers will compare the intervention and waitlist control groups to see if the intervention improves cognitive functioning.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:21+
Key Eligibility Criteria
Disqualifiers:Neurological, Psychiatric, GvHD, Metabolic, Others
80 Participants Needed
Ketogenic Diet for Cognitive Impairment After Surgery
Columbia, Missouri
Postoperative cognitive decline (POCD) is a significant neurological problem that commonly follows coronary artery bypass grafting surgery (CABG) in elderly patients. This can result in longer hospital stays and generate worsening morbidity and mortality. Furthermore, POCD often persists in some patients for more than a year and puts them at higher risk for developing Alzheimer's Disease or dementia. The cause of POCD is a topic of ongoing work, with recent hypotheses linked with cell dysfunction and death in the brain, and neuroinflammation related to the surgical trauma and related systemic inflammation. In this project, the investigators will test whether the pre-operative use (14 days) of a ketogenic diet (KD), compared to a control diet (CD) will lower the incidence, duration, and severity of POCD in cardiac patients. The ketogenic diet has been associated with improved memory function, as well as reduction of inflammation in conditions such as epilepsy, Alzheimer's Disease and Parkinson's Disease. A subset of patients from each group will also undergo a 7 Tesla magnetic resonance imaging and spectroscopy scan, where key brain metabolites of mitochondrial function and neuronal integrity will be measured in the prefrontal cortex and hippocampus. In the KD group, cerebral b-hydroxybutyrate (BHB) to evaluate cerebral ketosis will also be measured. These will be measured prior to starting the KD/CD and after a minimum of 10 days on the KD/CD. From both CD and KD groups, levels of key cytokines linked with inflammation will be measured during the protocol. Our outcome parameters for POCD will include measures that evaluate cognition, delirium and length of hospitalization. The following hypotheses will be investigated: 1) lower incidence, duration and severity of POCD in the KD group, compared to the CD group; and 2) better pre-operative values of neuronal integrity and in the KD group, higher levels of brain ketone levels will be associated with patients who do not experience POCD or have less severe POCD. This project tests the use of the multi-factorial effects of the KD for an important problem in Anesthesiology. With state-of-the-art imaging technology and cytokine evaluation, the investigators hypothesize this work can have substantial implications for prevention and management of postoperative cognitive decline.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:60+
Key Eligibility Criteria
Disqualifiers:Dementia, Alzheimer's, Parkinson's, Others
Must Not Be Taking:GLP-1 Agonists
40 Participants Needed
Ketosis for Bipolar Disorder
Stony Brook, New York
The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Seizure Disorders, Unstable Medical Illness, Others
Must Not Be Taking:Psychotropics, Insulin, Antidiabetics, Others
100 Participants Needed
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Frequently Asked Questions
How much do clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials?
Most recently, we added Ketogenic Diet for Cognitive Impairment After Surgery, Ketogenic Diet for Obesity and Ketogenic Diet for Infantile Spasms to the Power online platform.
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